Friday, February 8, 2008

The Future at FDA

Last week I attended the House Energy and Commerce Subcommittee on Oversight and Investigations hearing to examine the findings in the new report “FDA Science and Mission at Risk.” During the hearing witnesses reported on the deficiencies in the FDA’s scientific base and IT infrastructure. According to the report the FDA does not have the capacity to ensure the safety of food for the nation or the ability to protect Americans from excessive risks associated with drugs in the United States. (Finding 3.1.1)

FDA’s IT infrastructure creates numerous challenges across the Agency. In some cases electronic records do not exist and emergency backup systems are not in place. An example cited was that Banfield Pet Hospital’s 300 U.S. locations have adopted an electronic health record system for their pets. Meanwhile, the FDA has critical clinical trial data in paper documents stored in boxes at FDA facilities across the country. There is no electronic backup of these records and no one can access this vital information.

The challenges addressed in the report have plagued the Agency for years. In 1991, a previous committee reported to the Secretary of HHS its “deep concerns about the viability of the food programs and the lack of Agency priority for food issues. Decline in resources and program initiatives during the past 10-15 years indicate a lack of Agency management attention and interest in this area, although public interest in, and concern for, an effective food program remain high” (Report of the Advisory Committee on the Food and Drug Administration to the Secretary of HHS, May, 1991).

Though the report details major Agency challenges, FDA Commissioner Andrew von Eschenbach, M.D., testified that the scientific base at the FDA is strong but needs to be stronger. Dr. von Eschenbach sees the FDA “as the bridge, not the barrier.”

Who should be held accountable? FDA regulates all drugs, human vaccines, and medical devices, and plays a critical role in ensuring the efficacy of medical products. FDA regulates approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually. Without budget increases and improvement in IT and other capacities, it will become more difficult for the Agency to approve and regulate new, life-saving medical treatments in a timely manner, and much more difficult for us at FasterCures to save lives by saving time.

The FDA is a “brand” recognized across the world. It has been the gold standard for matters pertaining to the regulatory-approval and monitoring of drugs, biologics, and medical devices. Today, we are at the crossroads; the decisions of policymakers now will determine whether Americans can rest assured of the quality of the food they eat, and that the drugs that save lives are safe and effective.

Angelo R. Bouselli, Communications Manager, FasterCures